Tags

Type your tag names separated by a space and hit enter

Symptom bother and health-related quality of life outcomes following solifenacin treatment for overactive bladder: the VESIcare Open-Label Trial (VOLT).
Clin Ther. 2006 Nov; 28(11):1935-46.CT

Abstract

BACKGROUND

Most clinical trials designed to evaluate overactive bladder (OAB) syndrome treatments have focused on measuring micturition variables from bladder diaries. However, although diaries help physicians assess symptoms objectively, they lack information on patients' subjective experience of OAB symptoms and the effects of treatment.

OBJECTIVE

The objective of this study was to assess patients' perceptions of improvements in symptom bother and health-related quality of life (HRQOL) with solifenacin succinate 5- and 10-mg treatments in patients with OAB.

METHODS

VOLT (VESIcare Open-Label Trial) was a prospective, flexible-dosing trial performed at 207 centers in the United States. Ambulatory adult (aged > or = 18 years) men and women with an established diagnosis of OAB (urgency, urge urinary incontinence, frequency, and/or nocturia for > or = 3 months) and who provided a sterile urine sample received solifenacin QD for 12 weeks. Initially, all patients received 5 mg/d, with the option of adjustment to 10 mg/d at 4 and 8 weeks. Effectiveness was assessed using the Patient Perception of Bladder Condition (PPBC) scale, a visual analog scale (VAS) for the degree of bother caused by individual OAB symptoms, and the overactive bladder questionnaire (OAB-q). Assessments were performed at study initiation and study end or study termination. Adverse events (AEs) were assessed throughout.

RESULTS

Patients (N = 2225) were enrolled between June 2004 and April 2005. Patients with baseline data (n = 2205) had a mean (SD) age of 59.7 (14.4) years; most patients were women (1813 [82.2%]) and white (1761 [79.9%]). Of the total patients enrolled, 1743 (78.3%) completed all 12 weeks of the study. After 12 weeks of solifenacin treatment, improvement was observed in the mean values of patient-reported perception of bladder condition. Significant change was observed on the PPBC scale from the mean baseline value to study end (4.4 vs 2.9; P < 0.001). All subscales of HRQOL significantly improved on the OAB-q score (mean changes, 14.7 to 29.6; all, P < 0.001). On the VAS, there was a significant reduction in the degree of bother associated with urgency, urge urinary incontinence, frequency, and/or nocturia (mean changes in VAS ratings, -36.7 to -41.8; all, P < 0.001 vs baseline). Solifenacin was well tolerated in most patients. Treatment-emergent AEs were reported by 1321 (59.4%) patients. Most reported AEs were anticholinergic in nature and of mild to moderate severity: dry mouth, 477 (21.4%); constipation, 295 (13.3%); headache, 76 (3.4%); blurred vision, 57 (2.6%); nausea, 39 (1.8%); dyspepsia, 34 (1.5%); and dry eye, 29 (1.3%). Two hundred sixteen (9.7%) patients discontinued treatment due to AEs.

CONCLUSION

Flexibly dosed solifenacin 5 and 10 mg QD was associated with reductions in patient-reported OAB symptom bother and improvements in patients' perception of bladder condition and HRQOL.

Authors+Show Affiliations

Winthrop University Hospital, Division of Urogynecology and Reconstructive Pelvic Surgery, Mineola, New York 11501, USA. agarely@winthrop.orgNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

17213014

Citation

Garely, Alan D., et al. "Symptom Bother and Health-related Quality of Life Outcomes Following Solifenacin Treatment for Overactive Bladder: the VESIcare Open-Label Trial (VOLT)." Clinical Therapeutics, vol. 28, no. 11, 2006, pp. 1935-46.
Garely AD, Kaufman JM, Sand PK, et al. Symptom bother and health-related quality of life outcomes following solifenacin treatment for overactive bladder: the VESIcare Open-Label Trial (VOLT). Clin Ther. 2006;28(11):1935-46.
Garely, A. D., Kaufman, J. M., Sand, P. K., Smith, N., & Andoh, M. (2006). Symptom bother and health-related quality of life outcomes following solifenacin treatment for overactive bladder: the VESIcare Open-Label Trial (VOLT). Clinical Therapeutics, 28(11), 1935-46.
Garely AD, et al. Symptom Bother and Health-related Quality of Life Outcomes Following Solifenacin Treatment for Overactive Bladder: the VESIcare Open-Label Trial (VOLT). Clin Ther. 2006;28(11):1935-46. PubMed PMID: 17213014.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Symptom bother and health-related quality of life outcomes following solifenacin treatment for overactive bladder: the VESIcare Open-Label Trial (VOLT). AU - Garely,Alan D, AU - Kaufman,Joel M, AU - Sand,Peter K, AU - Smith,Neila, AU - Andoh,Masakazu, PY - 2006/09/22/accepted PY - 2007/1/11/pubmed PY - 2007/2/14/medline PY - 2007/1/11/entrez SP - 1935 EP - 46 JF - Clinical therapeutics JO - Clin Ther VL - 28 IS - 11 N2 - BACKGROUND: Most clinical trials designed to evaluate overactive bladder (OAB) syndrome treatments have focused on measuring micturition variables from bladder diaries. However, although diaries help physicians assess symptoms objectively, they lack information on patients' subjective experience of OAB symptoms and the effects of treatment. OBJECTIVE: The objective of this study was to assess patients' perceptions of improvements in symptom bother and health-related quality of life (HRQOL) with solifenacin succinate 5- and 10-mg treatments in patients with OAB. METHODS: VOLT (VESIcare Open-Label Trial) was a prospective, flexible-dosing trial performed at 207 centers in the United States. Ambulatory adult (aged > or = 18 years) men and women with an established diagnosis of OAB (urgency, urge urinary incontinence, frequency, and/or nocturia for > or = 3 months) and who provided a sterile urine sample received solifenacin QD for 12 weeks. Initially, all patients received 5 mg/d, with the option of adjustment to 10 mg/d at 4 and 8 weeks. Effectiveness was assessed using the Patient Perception of Bladder Condition (PPBC) scale, a visual analog scale (VAS) for the degree of bother caused by individual OAB symptoms, and the overactive bladder questionnaire (OAB-q). Assessments were performed at study initiation and study end or study termination. Adverse events (AEs) were assessed throughout. RESULTS: Patients (N = 2225) were enrolled between June 2004 and April 2005. Patients with baseline data (n = 2205) had a mean (SD) age of 59.7 (14.4) years; most patients were women (1813 [82.2%]) and white (1761 [79.9%]). Of the total patients enrolled, 1743 (78.3%) completed all 12 weeks of the study. After 12 weeks of solifenacin treatment, improvement was observed in the mean values of patient-reported perception of bladder condition. Significant change was observed on the PPBC scale from the mean baseline value to study end (4.4 vs 2.9; P < 0.001). All subscales of HRQOL significantly improved on the OAB-q score (mean changes, 14.7 to 29.6; all, P < 0.001). On the VAS, there was a significant reduction in the degree of bother associated with urgency, urge urinary incontinence, frequency, and/or nocturia (mean changes in VAS ratings, -36.7 to -41.8; all, P < 0.001 vs baseline). Solifenacin was well tolerated in most patients. Treatment-emergent AEs were reported by 1321 (59.4%) patients. Most reported AEs were anticholinergic in nature and of mild to moderate severity: dry mouth, 477 (21.4%); constipation, 295 (13.3%); headache, 76 (3.4%); blurred vision, 57 (2.6%); nausea, 39 (1.8%); dyspepsia, 34 (1.5%); and dry eye, 29 (1.3%). Two hundred sixteen (9.7%) patients discontinued treatment due to AEs. CONCLUSION: Flexibly dosed solifenacin 5 and 10 mg QD was associated with reductions in patient-reported OAB symptom bother and improvements in patients' perception of bladder condition and HRQOL. SN - 0149-2918 UR - https://www.unboundmedicine.com/medline/citation/17213014/Symptom_bother_and_health_related_quality_of_life_outcomes_following_solifenacin_treatment_for_overactive_bladder:_the_VESIcare_Open_Label_Trial__VOLT__ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0149-2918(06)00280-3 DB - PRIME DP - Unbound Medicine ER -